NCT04636827

Evaluation of Safety and Immunogenicity of Combined Immunization of sIPV, DTaP and HepA

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 18 Months – 19 Months
• Healthy volunteers: Accepted

Summary

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows: 1. Group 1: sIPV + DTaP + HepA, 2. Group 2: sIPV only, 3. Group 3: DTaP only, 4. Group 4: HepA only. The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.

Detailed description

Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines. To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ HepA(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives HepA (0.5ml). Blood samples will be collected before vaccination and 30-40 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.

Conditions

• Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	sIPV+DTaP+HepA	sIPV+DTaP+HepA at the age of 18 month old
BIOLOGICAL	sIPV	sIPV at the age of 18 month old
BIOLOGICAL	DTaP	DTaP at the age of 18 month old
BIOLOGICAL	HepA	HepA at the age of 18 month old

Timeline

• Start date: 2020-11-11
• Primary completion: 2021-08-01
• Completion: 2021-12-01
• First posted: 2020-11-19
• Last updated: 2020-11-19

Locations

3 sites across 1 country: China